A Study of Verutex (Fusidic Acid), Eritex (Erythromycin) and Fisiogel in the Management of Tarceva-Associated Rash. - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00718315

Purpose

This 3 arm study will compare the efficacy and safety of three different dermatological creams designed for prophylaxis of skin rash associated with Tarceva treatment in patients with locally advanced or metastatic non-small cell lung cancer. Eligible patients who have recently started Tarceva treatment will be randomized to one of 3 groups, to receive daily treatment with Verutex, Eritex or Fisiogel cream for 30 days, and the incidence and severity of skin rash will be assessed. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: erlotinib [Tarceva] Drug: fusidic acid [Verutex] Drug: erythromycin [Eritex] Drug: Fisiogel	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Open Label Study to Compare the Use of the Dermatological Creams Verutex, Eritex and Fisiogel in the Management of Skin Rash Associated With Tarceva Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Rashes

Drug Information available for: Erythromycin Erythromycin stearate Erythromycin ethylsuccinate Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Percentage of patients who develop skin rash [ Time Frame: Day 27-36 of Tarceva treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of treatment discontinuation due to skin rash [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Time to appearance of skin rash [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
AEs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	312
Study Start Date:	March 2009
Estimated Study Completion Date:	September 2012

Arms	Assigned Interventions
Experimental: 1	Drug: erlotinib [Tarceva] 150mg po daily Drug: fusidic acid [Verutex] topical, daily for 30 days.
Experimental: 2	Drug: erlotinib [Tarceva] 150mg po daily Drug: erythromycin [Eritex] topical, daily for 30 days.
Experimental: 3	Drug: erlotinib [Tarceva] 150mg po daily Drug: Fisiogel topical, daily for 30 days

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients, >=18 years of age;
locally advanced or metastatic non-small cell lung cancer (stage IIIB/IV);
eligible to start treatment with Tarceva, or receiving Tarceva for <=5 days.

Exclusion Criteria:

presence of skin rash or other signs of skin toxicity;
treatment with any systemic or intranasal antibiotic within 7 days before randomization;
treatment with other topical formulation within 14 days before randomization;
other anticancer therapy in addition to Tarceva.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718315

Contacts

Contact: Please reference Study ID Number: ML21450

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Locations

Brazil
	Completed
Belo Horizonte, Brazil, 30150-320
	Completed
Belo Horizonte, Brazil, 30150-281
	Active, not recruiting
Curitiba, Brazil, 80010030
	Not yet recruiting
Curitiba, Brazil, 80530-010
	Completed
Curitiba, Brazil, 80810-050
	Completed
Divinópolis, Brazil, 35500-222
	Recruiting
Fortaleza, Brazil, 60190-800
	Recruiting
Fortaleza, Brazil, 60125-151
	Completed
Goiânia, Brazil, 74140-050
	Completed
Ijuí, Brazil, 98700-000
	Active, not recruiting
Itajai, Brazil, 88310-110
	Completed
Natal, Brazil, 59040150
	Active, not recruiting
Porto Alegre, Brazil, 90430090
	Recruiting
Recife, Brazil, 50070-170
	Completed
Ribeirão Preto, Brazil, 14025-430
	Completed
Rio de Janeiro, Brazil, 22260-020
	Not yet recruiting
Rio de Janeiro, Brazil, 22631-004
	Completed
Salvador, Brazil, 40110-150
	Active, not recruiting
Salvador, Brazil, 40170-110
	Recruiting
Salvador, Brazil, 41830492
	Completed
Sao Paulo, Brazil, 05651-901
	Completed
Sao Paulo, Brazil, 01401-901
	Completed
Sao Paulo, Brazil, 01308-000
	Active, not recruiting
Sao Paulo, Brazil, 01221-020
	Active, not recruiting
Sao Paulo, Brazil, 04039-901
	Completed
São Paulo, Brazil, 01323-000
	Completed
Taguatinga, Brazil, 72115-700

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00718315 History of Changes
Other Study ID Numbers:	ML21450
Study First Received:	July 16, 2008
Last Updated:	May 21, 2012
Health Authority:	Brazil: Ministry of Health

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erythromycin stearate
Erythromycin
Erythromycin Estolate

Erythromycin Ethylsuccinate
Fusidic Acid
Erlotinib
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on May 23, 2012